Download NSW TAG Pain Guidance

Preventing and managing
problems with opioid prescribing
for chronic non-cancer pain
July 2015
An initiative of NSW clinical pharmacologists and pharmacists funded by the NSW Ministry of Health
Abbreviations
CNCP
chronic non cancer pain
COPD
chronic obstructive pulmonary disease
g
gram(s)
GP
general practitioner
IM
intramuscular
IV
intravenous
LSD
lysergic acid diethylamide
MAOI
monoamine oxidase inhibitor
mg
milligram(s)
NSW
New South Wales
OMEDD
oral morphine equivalent daily dose
PEG
Pain-Enjoyment-General Activity scale of pain
intensity and interference
PSU
NSW Ministry of Health Pharmaceutical Services
Unit
SC
subcutaneous
SNRI
serotonin noradrenaline reuptake inhibitor
SSRI
selective serotonin reuptake inhibitor
TCA
tricyclic antidepressant
New South Wales Therapeutic Advisory Group Inc
Address:
NSW TAG
26 Leichhardt St,
Darlinghurst
NSW 2010
Phone: (02) 8382 2852
Email: [email protected]
Web: www.nswtag.org.au
Recommended citation: NSW Therapeutic Advisory Group Inc.
Preventing and managing problems with opioid prescribing
for chronic non-cancer pain.
NSW TAG: Sydney, 2015
ISBN: 978-0-9586069-0-5
2
NSW TAG | New South Wales Therapeutic Advisory Group Inc
© NSW Therapeutic Advisory Group Inc
and State of New South Wales (through the Ministry of Health) 2015
Contents
Abbreviations ................................................................................................................................................................................ 2
Key messages ............................................................................................................................................................................... 4
Risk mitigation strategies ............................................................................................................................................................ 4
Purpose of guidance .................................................................................................................................................................... 5
Background ................................................................................................................................................................................... 5
Comprehensive assessment ....................................................................................................................................................... 6
Management of chronic non-cancer pain ................................................................................................................................... 7
Non-pharmacological strategies .......................................................................................................................................... 7
Pharmacological strategies.................................................................................................................................................. 7
Use of opioids ...................................................................................................................................................................... 7
Conduct of an opioid trial ..................................................................................................................................................... 8
Reducing the dose of opioids .............................................................................................................................................. 9
Adverse effects of opioids ................................................................................................................................................. 10
When to refer a patient to a specialist pain medicine physician? ...................................................................................... 10
Role of urinary drug screens ............................................................................................................................................. 10
Regulatory requirements and prescription monitoring programs ........................................................................................ 11
NSW Ministry of Health, Pharmaceutical Services Unit .................................................................................................... 11
Medicare Australia ............................................................................................................................................................ 11
Scenarios .................................................................................................................................................................................... 12
1. Adult patient with low back pain for six weeks .............................................................................................................. 12
2. Adult patient discharged from hospital after surgery ..................................................................................................... 12
3. Poor control of CNCP despite increasing opioid dose .................................................................................................. 13
4. “Drug-seeking” in the context of dependency/addiction ................................................................................................ 14
5. Older person with multiple sites of pain ........................................................................................................................ 14
6. Transfer of care: adult patient using injectable opioids ................................................................................................. 15
7. Adult patient with stable pain post cancer treatment ..................................................................................................... 15
References ................................................................................................................................................................................. 16
Appendices ................................................................................................................................................................................ 17
Process of guidance development .................................................................................................................................... 17
Acknowledgements .......................................................................................................................................................... 17
Preventing and managing problems with opioid prescribing for chronic non-cancer pain | July 2015
3
Key messages
A multidisciplinary approach with a focus on active self-management is recommended for
patients with CNCP.
Evidence does not support the routine use of opioids in the management of CNCP.
However, if opioids are selected as part of a management plan for CNCP, the following principles
are recommended:
-
Negotiate a trial of opioid therapy that explicitly identifies goals and duration of therapy
-
Keep oral morphine equivalent daily dose (OMEDD) ≤ 60mg
-
Seek specialist advice if uncertain about advisability or conduct of the trial
Opioids should be withdrawn if:
-
Acute pain episodes have resolved, or
-
There is no improvement in function during the trial, or
-
Adverse effects or other risks of therapy outweigh any benefit, or
-
Aberrant behaviours develop.
After a successful trial of opioid therapy, as indicated by improved function and quality of life, ongoing
treatment should be renegotiated on a regular basis, to include goals, duration and lowering of dose.
Risk mitigation strategies
Check whether other prescribers have been involved in the patient’s pain management.
Avoid prescribing multiple opioids.
Beware of prescribing opioids with other central nervous system depressants.
Check for aberrant drug-related behaviours.
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NSW TAG | New South Wales Therapeutic Advisory Group Inc
Purpose of guidance
The use of opioids for the long term management of chronic non-cancer pain (CNCP) is
controversial. A multidisciplinary approach that emphasises non-pharmacological over
pharmacological treatment and promotes self-management is generally preferred. However, it is also
recognised that medicines including opioids can play a role in selected cases.
This practical guidance on the rational use of opioids is intended to assist clinicians to manage the complex medical, ethical
and regulatory issues that arise when using opioids for chronic pain in adults in primary care. It is based on the best available
evidence or expert consensus where research evidence is lacking.
This guidance does not extend to children and adolescents with CNCP. In this situation specialist advice should be sought.
Background
One in five people report chronic pain, defined as pain experienced every day for three or more
months. [1] For many, a biomedical ‘cure’ may not be realistic. However, it is generally possible to
reduce pain and achieve and maintain an acceptable level of function in personal, social and
occupational life by adopting an active self-management approach.
Patients with CNCP may present for management of:
ongoing pain, or
an exacerbation of CNCP, or
acute pain from an unrelated injury or illness, or
side effects from treatment.
The importance of a multidisciplinary and multidimensional
approach that does not rely on drug therapy alone cannot
be over-emphasised.
The following resources are available for patients, carers
and family members:
A short video about the causes and management of
CNCP
A fact sheet about the nature and science of pain
A video about the use of medications, particularly opioids,
for CNCP
Preventing and managing problems with opioid prescribing for chronic non-cancer pain | July 2015
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Comprehensive assessment
Assess each patient for physical, psychological and sociological contributors to pain and for potential
problems if opioids are used.
A comprehensive assessment is likely to require a longer
follow-up appointment.
Comprehensive assessment of CNCP addresses:
Clinical features that might indicate underlying conditions
such as inflammation, infection, neural pathology and
neoplasm that require further evaluation and specific
treatment (‘red flags’).[2]
To inform assessment of CNCP in primary care, the brief
three-item validated pain scoring system, PEG (PainEnjoyment-General Activity scale), can be used (Box 1).
Scores (out of 30) give a reference point for the patient’s
overall wellbeing and can be used to compare the same
patient seen at different times or by different practitioners.
[See Scenarios 4 and 6]
Patient beliefs and understanding about diagnosis,
prognosis, physical activity, work, recreation, nutrition,
sleep, depression, anxiety, and self-esteem, sometimes
referred to as ‘yellow flags’.
Abbey and Faces pain scales are alternative tools to help
assess patients with cognitive impairment, dementia or those
from non-English speaking backgrounds.[4]
A thorough medication history including use of overthe-counter and complementary medicines.
A standardised mental health assessment and a drug
and alcohol history.
Box 1: Pain-Enjoyment-General Activity scale
1. What number best describes your pain on average in the past week?
0
1
2
3
4
5
6
7
8
9
No pain
10
Worst possible
pain
2. What number best describes how pain has interfered with your enjoyment of life in the past week?
0
1
2
3
4
5
6
7
8
9
Does not interfere
10
Completely
interferes
3. What number best describes how pain has interfered with your general activity in the past week?
0
1
2
3
4
5
Does not interfere
Adapted from Krebs et al [3]
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NSW TAG | New South Wales Therapeutic Advisory Group Inc
6
7
8
9
10
Completely
interferes
Management of chronic non-cancer pain
Non-pharmacological strategies
Pharmacological strategies
Non-pharmacological strategies that support active selfmanagement of CNCP, whether opioids are used or not, include:
counselling (may be available online or via telephone)
Pharmacological strategies may include use of paracetamol,
non-steroidal anti-inflammatory drugs (either non-selective
or COX-2 inhibitors), and adjuvant drugs, such as some
antidepressants or antineuropathic agents, for symptom
control or in some cases to influence mechanism of
pain production.
relaxation therapy/mindfulness/yoga
Use of opioids
cessation of smoking
There is good evidence for the use of opioids in acute pain,
pain associated with cancer, palliation at the end of life
and the management of opioid dependence.[5-8] Evidence
does not support the long-term effectiveness of opioids
in CNCP. Opioids may have a short-term role while nonpharmacological strategies are being introduced. Once
these are established the standard approach is gradual
opioid withdrawal towards cessation.
planned daily walks or exercise(s)
physiotherapy/hydrotherapy
nutritional change with support from a dietitian
attending a group pain management program
social connection
[See Scenarios 1, 5 and 6]
If there is difficulty in establishing these strategies due to
the patient’s access, ability or willingness to participate,
then telephone advice can be sought from specialist
pain medicine physicians, pain centres or other health
professionals prior to a consultation (or in lieu of a
consultation where it is impractical e.g. rural areas, long
waiting times).
A prescriber may choose NOT to use opioids OR to
undertake a brief trial of opioids possibly followed, if
successful, by a time-limited continuance phase.
The aim of an opioid trial is:
to determine if a patient’s condition is opioid responsive,
and
to establish the lowest dose to achieve a pre-determined
improvement in function (such as using the PEG)
and quality of life (such as return to work or social
engagement). This dose may be ZERO.
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Conduct of an opioid trial
An opioid trial entails:
comprehensive assessment
concurrent use of non-pharmacological strategies
negotiation with the patient regarding agreed goals in
terms of functional outcomes and duration of treatment
risk assessment to determine duration of prescription
and frequency of dispensing
regular review of opioid use according to the 5As [9]:
-
Activity
-
Adverse effects
-
Aberrant behaviour (behaviour suggestive
of opioid misuse – see Figure A)
-
Affect (overall presentation of the patient)
-
Analgesia
Information on individual agents is available. If opioids are
trialled for management of CNCP, long-acting (modifiedrelease) preparations taken on a regular basis are preferred.
Lower doses of these can be used to supplement on
a “when required” basis rather than using immediaterelease preparations. An oral morphine equivalent daily
dose (OMEDD) of 60mg should not be exceeded without
specialist advice.
The following should NOT be used in an opioid trial for
CNCP:
immediate-release opioids
injectable opioids, e.g. pethidine, morphine
review at least every 1-2 weeks during the 4-8 week trial
phase, then regularly if there is a time-limited
continuance phase
methadone (without specialised advice, including advice
on dose conversion) due its complicated
pharmacokinetics
hydromorphone (without specialist advice) due to the
high oral morphine equivalent dose of the lowest
available dose formulations
fentanyl (without specialist advice) due to the high oral
morphine equivalent dose of the lowest available
dose formulations
Older adults are more sensitive to opioids. If opioids are
used, the starting dose should be 25 - 50% of the usual
adult dose, adjusted carefully depending on response and
monitored frequently for analgesic and adverse effects.[4]
Any beneficial response to an opioid in a trial should be
evident at an OMEDD ≤ 60mg. Wean and cease the opioid
or seek consultation if OMEDD is approaching 60mg without
obvious improvement in function and quality of life.
Figure A. Spectrum of aberrant drug-related behaviours [10]
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Table 1 can be used to calculate an approximate OMEDD of an opioid. [See Scenarios 3-7]
Table 1. Guide to Opioid Equivalence
This table has been developed by Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists for
the purpose of comparing opioid regimens. The intention is to illustrate the relative potency of different opioids by converting
to an approximate oral morphine equivalent daily dose (OMEDD).¥
The conversion factors listed are the consensus view of an expert panel derived from the best evidence available. However,
they are derived from group studies and may not be appropriate for any given individual. Various factors influence the
metabolism and excretion of opioids, particularly hepatic and renal status, and increasing age.
Hence caution is recommended if these conversion factors are used to guide opioid switching in clinical practice.
If opioid rationalising is undertaken a conservative approach involves converting to a new opioid at 50-60% of the
equianalgesic dose as determined from the table. Consultation with an experienced colleague or a pain medicine or addiction
medicine specialist may be helpful.
Route of
administration
Oral (swallowed)
Sublingual
Transdermal
Injectable
Rectal
Opioid
Unit
codeine
mg/day
Conversion
0.13
dextropropoxyphene mg/day
0.1
hydromorphone
mg/day
5
morphine
mg/day
1
oxycodone
mg/day
1.5
tapentadol
mg/day
0.4
tramadol
mg/day
0.2
buprenorphine
mg/day
40
buprenorphine
micrograms/hr
2
fentanyl
micrograms/hr
3
morphine (sc, iv)
mg/day
3
oxycodone (sc, iv)
mg/day
3
pethidine (iv, im)
mg/day
0.4
oxycodone
mg/day
1.5
Example
Codeine phosphate 30mg (as
Panadeine Forte®), 8 per day
represents codeine 240mg per
day which is approximately
equianalgesic with oral
morphine 30mg (240 x 0.13) per
day (OMEDD). If considering
changing to modified-release
oxycodone, the starting dose
would be 5mg twice daily which
is equivalent to 15mg OMEDD
(ie 50% of 30mg).
¥
This table is an abridged version
omitting proprietary names and
injectable preparations less
commonly used in primary care.
A number of available opioid products are perceived to carry less risk of overdose, dependence or diversion (“tamper resistant”).
However, these problems can occur with ANY opioid product.
Reducing the dose of opioids
Dose reduction, with the goal of cessation of opioids,
is indicated:
•
•
•
•
where there is a lack of effectiveness (unsuccessful trial)
at the end of the agreed continuance phase
where adverse effects are limiting
where opioids are misused
If cessation is not achieved, the aim is to determine the
lowest dose of opioid associated with improved function and
quality of life.
If more than one opioid is currently being used, the
regimen should be rationalised to a single oral modifiedrelease opioid. [See Table 1] When stabilised, the dose
of opioid should be reduced gradually over a time period
as negotiated with the patient, supported by active selfmanagement. Although there is no evidence regarding
the ideal rate for dose reduction, the following consensus
approaches have been used successfully:
(a) fast reduction by 10 – 25 % of the daily dose per week,
[See Scenarios 2 and 4], or
(b) slow reduction by a 10 – 25 % of the daily dose per
month if a patient has been using opioids for some years.
[See Scenarios 3, 6 and 7]
A prescriber is under no obligation to continue opioids
against their better judgement. The prescriber can insist on
dose reduction/cessation or consult a specialist for advice.
Preventing and managing problems with opioid prescribing for chronic non-cancer pain | July 2015
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Adverse effects of opioids
A range of adverse effects beyond constipation and sedation
can occur. The risk and severity of adverse effects is
increased when opioids are used:
Table 2. Drugs that may contribute to
serotonin toxicity [12]
Class
Drugs
antidepressants
MAOIs (including moclobemide),
SNRIs, SSRIs, St John’s wort, TCAs
opioids
dextromethorphan, fentanyl, pethidine,
tramadol, tapentadol
in patients with co-morbid respiratory disease or hepatic
or renal impairment
stimulants
hallucinogenic amphetamines,
phentermine
in patients with acute illness that might impair hepatic or
renal function (due to reduced opioid elimination)
others
illicit drugs (e.g. ‘ecstasy’, LSD,
cocaine), rasagiline, selegiline,
linezolid, lithium, methylene blue,
tryptophan
concurrently with medicines with sedating effects,
particularly benzodiazepines, or alcohol
in older patients
Frequent review is needed in all circumstances.
Serotonin syndrome has been reported with tramadol,
fentanyl and pethidine, particularly when used concurrently
with other serotonergically-active agents including overthe-counter and complementary medicines.[11] [See Table 2]
Isolated reports have also occurred with tapentadol.
Combination analgesics such as codeine and ibuprofen
or dextropropoxyphene and paracetamol carry additional
significant risks (e.g. dependence, gastrointestinal
ulceration, cardiotoxicity) with little additional efficacy.
Patients on opioids may need regular laxative prescription.
When to refer a patient to a specialist pain medicine physician?
Specialist advice is recommended for any patient:
taking OMEDD > 60mg (or > 30mg in patients who are elderly or who have co-morbidities impairing renal or hepatic
function),
with moderate to high levels of psychological distress associated with pain,
using an opioid for > 90 days,
failing to respond to multidisciplinary management in primary care.
Role of urinary drug screens
When carried out before and irregularly during opioid
prescribing, urinary drug screens can be helpful to:
• corroborate patient self-reports,
• identify aberrant behaviour (e.g. use of other or illicit
substances), and
• monitor compliance with pain management plans.
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Unexpected results from such screens should be interpreted
within their limitations: fentanyl, buprenorphine, synthetic
drugs, anabolic steroids, and usually oxycodone are not
routinely detected and must be requested as additional
tests (at extra cost to the patient). Drug misusers may adopt
a variety of methods, such as switching urine samples, to
influence results.
Regulatory requirements and prescription monitoring programs
There are jurisdictional differences between states with regard to authority requirements:
[ACT] [NSW] [NT] [QLD] [SA] [TAS] [VIC] [WA]
NSW Ministry of Health, Pharmaceutical
Services Unit
GPs can report concerns about patients misusing opioids to
PSU (or the appropriate authority in the jurisdiction).
An Authority from PSU is required for a medical practitioner
to prescribe a Schedule 8 drug of addiction if a patient is
considered ‘drug dependent’. The Authority, issued under
the Poisons and Therapeutic Goods Act 1966, not only
ensures the prescribing is legal but provides a regulatory
structure to manage the prescribing. It limits the prescribing
to one practitioner and provides a maximum dose that
cannot be exceeded. It can include mandatory conditions
such as structured reduction regimens, urinary drug screens
and staged supplies to avoid dose escalation or diversion,
and referral to multidisciplinary specialist services.
Note: The Authority from the NSW Ministry of Health is the
legal authority to prescribe the drug. It is independent of
an authority from Medicare Australia to prescribe under the
Pharmaceutical Benefits Scheme (PBS), which is solely
for the purpose of subsidising the medication cost to the
patient.
If a patient is not considered drug dependent an Authority
will be required to prescribe the following Schedule 8 opioids
beyond 8 weeks:
Additionally a prescriber may consider obtaining the
patient’s permission to authorise Medicare Australia to
release Medicare or Pharmaceutical Benefits Scheme
claims information to a third party.
• any injectable or inhaled formulation
• methadone, buprenorphine (excluding transdermal) and
Medicare Australia
Medicare Australia administers a Prescription Shopping
Information Service:
Ph: 1800 631 181
hydromorphone
This Authority has a maximum duration of 6 months. [See
Scenarios 3-7]
An explanation of legal requirements and further information
(including the storage and disposal of opioids) is available or
speak to a Senior Pharmaceutical Officer Ph: 02 9424 5923.
Preventing and managing problems with opioid prescribing for chronic non-cancer pain | July 2015
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Scenarios
Scenario 1 : Adult patient with low back pain for six weeks
A 45-year-old man developed acute low back pain six weeks ago as he was unloading camping equipment whilst arguing
with his wife on a family holiday. Despite early physiotherapy his pain has persisted and he has continued to use overthe-counter codeine/paracetamol 10/500mg tablets with marginal benefit. He visits his general practitioner (GP) after the
holiday and requests stronger analgesics and spinal imaging. No clinical ‘red flag’ features are present, but he is fearful of
structural damage.
Recommended approach:
His GP explains and reassures him that spinal imaging and surgical opinion are unnecessary because there are no clinical
features to suggest a harmful underlying condition. He is advised to cease codeine since opioids are unlikely to be of
benefit in this situation. A management plan is developed that includes giving patient information on the neurobiology
of pain, a staged return to functional activity, education about the linkage between mind and body and the potential
contribution to nervous system sensitisation of unresolved emotions. The patient agrees to see his physiotherapist for
mobility exercises and undertake relaxation therapy.
Key Message:
Opioids are unlikely to be effective for episodes of non-”red flag” low back pain that persist beyond the usual
natural history of recovery.
Scenario 2: Adult patient discharged from hospital after surgery
A 55-year-old man was discharged from hospital on modified-release oxycodone 20mg twice daily following admission for
surgery. He visits his GP for follow-up medication seven days later.
Recommended approach:
Since the acute pain phase (related to the nociception of acute injury) has passed and he is healing satisfactorily, the
modified-release oxycodone can be quickly decreased (for example by 10mg of the daily dose per week). Paracetamol
can be used if required, with further review depending on clinical progress. Giving the patient a clear explanation of these
steps is an important role for the GP.
Note: There is a risk of discharge medication being continued indefinitely if there has been poor communication between
health practitioners or because of patient distress.
Key Message:
Opioids initiated for acute pain should be reduced and ceased at the earliest opportunity.
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NSW TAG | New South Wales Therapeutic Advisory Group Inc
SCENARIO 3
Scenario 3: Poor control of CNCP despite increasing opioid dose
A 62 year old man has had chronic low back pain since a work-related injury ten years ago. This was initially managed
with modified-release morphine but over the years with development of osteoarthritis, a motor vehicle accident and
several falls, modified-release morphine was replaced by modified- and immediate-release oral oxycodone. Another
specialist recommended patches, and after the latest hospital admission oral morphine solution was added for ease of
swallowing. The patient states that he requires all these opioids to control his pain.
The patient is currently taking codeine/paracetamol 30/500mg x two tablets four times a day, modified-release oxycodone
60mg three times a day, immediate-release oxycodone 10mg x two tablets when required if the weather is cold,
transdermal fentanyl 75 micrograms/hour every 3 days and oral morphine solution 20mg when required for exacerbation
of pain. The OMEDD of this regimen is at least 500mg:
Medicine
Route
Daily dose
Conversion factor
OMEDD
Codeine
Oral
240mg
0.13
30mg
Oxycodone modified-release
Oral
180mg
1.5
270mg
Oxycodone when required
Oral
40mg
1.5
60mg
Morphine solution when required
Oral
20mg
1
20mg
Fentanyl patch
Topical
75 micrograms/hour
3
225mg
Total 605mg
Recommended approach:
His new GP discusses the lack of scientific evidence for long-term opioid therapy. He has telephone discussions with a
local pain medicine specialist regarding an appropriate management plan and the NSW Ministry of Health Pharmaceutical
Services Unit to obtain advice on the Authority application process and information on local specialist services. The
GP and patient negotiate and agree a plan to convert to a single modified-release opioid at OMEDD 320mg, stabilise
the dose, then slowly reduce and cease it over eight months while putting in place supported multidisciplinary selfmanagement strategies. Adjuvant use of pregabalin or gabapentin could be considered.
Note: This case is an extreme example of what can happen over time with multiple prescribers, poor communication and
the absence of a pain management plan.
Although there is no evidence of behaviour suggesting opioid misuse, the patient may be considered ‘drug dependent’
based on the extreme OMEDD of 605mg. Medical practitioners are advised to apply to PSU for an Authority to prescribe
ANY Schedule 8 drug. [See Regulatory requirements]
Key Messages:
Check whether other prescribers have been involved in the patient’s pain management.
Negotiate a pain management plan with all patients on opioids with the view to minimising dose.
Preventing and managing problems with opioid prescribing for chronic non-cancer pain | July 2015
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Scenario 4: “Drug-seeking” in the context of dependency/addiction
A 48 year old man with a history of substance use and binge drinking in his twenties has presented with chronic ankle pain
following a fall from a ladder. His GP prescribed transdermal fentanyl patches as an ‘abuse-proof’ formulation. There are
concerns that he is diverting the patches. Frequently scripts have been presented early because the patient claims that
the patches have fallen off. Each time he has a consultation with his GP he has the patch on and there are no obvious
track marks.
Currently he is prescribed transdermal fentanyl 75 micrograms/hour every three days. He has not been identified by the
Prescription Shopping Information Service and there have been no recent reports to PSU or the relevant state regulatory
body. His urine drug screen, which specifically included fentanyl assay, showed only fentanyl. He complains that 75
micrograms/hour is not controlling the pain or enabling sleep and he requests stronger patches. He has not regained
regular employment due to his problem as he can hardly cope with things at home. His partner also has health
problems. His PEG scores remain between 24 and 27.
Recommended approach:
This ‘opioid trial’ has failed. Behaviours suggesting opioid misuse are present. Consider the following:
• Conversion: The patient’s dose should be reduced by using the ‘fast’ approach with either lower dose patches or by
switching to an oral modified-release opioid. Transdermal fentanyl 75 micrograms/hour is approximately equivalent to
OMEDD 225mg. An appropriate starting daily dose of modified-release oral morphine would be 120-150mg (i.e. half of
the original OMEDD).
• Collaboration: It is recognised that these situations can be confronting and potentially threatening to the practitioner.
Advice from other health professionals involved in patient care is recommended. (Contact with professional societies for
guidance in managing difficult situations or patients is suggested).
• Containment: Opioid supply can be dispensed as a daily to weekly pick up from the patient’s pharmacy with frequent
(weekly) review to address concerns about his medication control. Note: This staged medication supply differs from
supervised supply where the patient is actually observed taking their medication by dispensing staff.
This is an example of a ‘drug dependent’ patient according to the Poisons and Therapeutic Goods Act 1966 and therefore
an Authority from the NSW Ministry of Health is required prior to prescribing.
Scenario 5: Older person with multiple sites of pain
An 85 year old woman has chronic pain associated with osteoarthritis. Despite regular paracetamol, her joint pain limits her
ability to perform activities of daily living. Non-steroidal anti-inflammatory drugs are unsuitable considering her co-morbidities.
Her regular medicines are paracetamol 1g three times a day, perindopril 4mg daily, indapamide 1.25mg daily, atorvastatin 40mg
daily, citalopram 20mg daily, omeprazole 40mg daily, vitamin D 1000 units daily and temazepam 10mg at night when required.
Her GP commenced her on transdermal buprenorphine 5 micrograms/hour and observed good functional improvement.
After six months pain was again limiting her independence, and her GP added modified-release oxycodone 5mg twice
daily. Three months later she sustained a crush fracture of a lumbar vertebra in a fall. The pain was managed initially with
immediate-release oxycodone, which was changed to modified-release oxycodone 10mg twice daily. A year later, she
was still using transdermal buprenorphine 5 micrograms/hour (OMEDD 10mg) and modified-release oxycodone 10mg twice
daily (OMEDD 30mg). She still had pain limiting her activities of daily living, was having recurrent falls, had developed mild
cognitive impairment, and could no longer manage at home.
Recommended approach:
If opioids were to be used with the increase in chronic pain after six months this patient should have been treated with a
single agent: either transdermal buprenorphine, or modified-release oral opioid. Prescribing multiple opioids increases the
risk of adverse effects.
The increase in her opioid dose required three months later after the crush fracture should have been reviewed after 4-6
weeks when the acute pain component should have resolved. The cumulative dose at this time, OMEDD 40mg, was higher
than most older patients can tolerate. She may have benefitted from a Home Medicines Review. Her exposure to centrally
acting drugs, including opioids, citalopram and temazepam, should be minimised as these drugs all increase the risk of falls,
cognitive impairment and functional dependence. Physiotherapy or hydrotherapy might also support her.
It is unlikely that this patient would be considered drug dependent according to the Poisons and Therapeutic Goods Act.
Therefore an Authority from PSU would not be required to prescribe transdermal buprenorphine or oral oxycodone.
Key Messages:
Avoid prescribing multiple opioids.
Beware of prescribing opioids with other central nervous system depressants.
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NSW TAG | New South Wales Therapeutic Advisory Group Inc
SCENARIO 6
Scenario 6: Transfer of care: adult patient using injectable opioids
A 56 year old woman with recurring headaches is wheelchair-bound and has a long history of pain-associated dependent
behaviour. Her long-term GP retired last year, having prescribed her morphine ampoules 30mg three times a day for self-injection
for approximately twelve years. The last Authority from PSU for the injections expired ten years ago. Oral morphine solution
10mg/mL when required has recently been added. She has not visited a pain clinic for four years and is unwilling to attend
again as the recommendation at the last visit was to transfer to a long-acting oral opioid formulation. The patient has never
prescription-shopped or used illicit drugs. Her current PEG score is 28 but no pain measurements were done by the previous
doctor. She has reported intolerance to other opioids. She has also trialed botulinum toxin injections, lignocaine infusions and
other alternative migraine therapies but reports that only opioid injections give any real relief. She has taken diazepam 1015mg a day for anxiety and occasional oxazepam at night for many years. A GP in the same practice has agreed to take over
management of this patient but is not happy with the situation.
Recommended approach:
The patient’s pain management plan requires revision. There is no justification for continuing injectable morphine in this
patient. The oral morphine solution and benzodiazepines add to the risk of serious adverse events including death.
The complexity of this case is best managed by a specialist and the nearest pain clinic can be contacted initially for
telephone advice. The OMEDD of her current injectable regimen is more than 270mg/day. The patient needs to be gradually
switched to a single oral opioid, “capturing” the current opioid requirement, ultimately in a long-acting formulation such as
oral modified-release morphine. After stabilisation, this can be titrated down slowly, for example by 10mg of the daily dose
per month. Regular review and ongoing patient education is necessary. Smoking cessation may help manage her pain; she
may also benefit from slow reduction and cessation of benzodiazepines.
The prescribing of injectable drugs of addiction for longer than two months requires an Authority from PSU. Applications are likely
to be referred to the Ministry of Health Medical Committee for a recommendation. Medical practitioners who ‘inherit’ patients on
established, entrenched regimens of injectable opioids are advised to seek advice from a Senior Pharmaceutical Officer at PSU as
soon as possible.
Key Messages:
There is no role for injectable opioids in CNCP.
Seek early specialist advice from the nearest pain clinic and from PSU by telephone or email for any new patient using
injectable opioids.
Scenario 7: Adult patient with stable pain post cancer treatment
A 32 year old man underwent curative treatment for osteosarcoma of the distal right femur with above-knee amputation
and chemotherapy. He had leg pain pre-operatively and has had phantom limb pain in his right leg post-surgery. He is now
taking modified-release morphine 200mg twice daily, immediate-release liquid morphine 20mg when required (up to
160mg daily) and pregabalin 75mg twice daily. He denies any other substance use, but reports high levels of anxiety about
body image and using his prosthesis.
Recommended approach:
A comprehensive assessment is needed to distinguish between stump pain, phantom limb pain and cancer recurrence. In
this case the management approach needs to be altered since he no longer has cancer pain.
Frequent use of an immediate-release opioid formulation causes a withdrawal/intoxication cycle. All opioids should be
rationalised to an appropriate dose of modified-release opioid, in this case morphine. The patients current OMEDD is
560mg. However a daily dose which is less than the sum of the immediate- and modified-release doses, for example
340mg, should be tried with frequent review. Once the opioid dose has been stabilised, it would be maintained for
some weeks/months while pregabalin is increased and assessed for effectiveness (or other treatments, including nonpharmacological interventions, added) before being slowly reduced and ceased.
Given the patient’s high opioid use, telephone advice from a pain specialist should be sought ahead of a specialist
appointment. A multidisciplinary review assessing the patient’s anxiety and function with prosthesis is important.
Although there is no evidence of behaviour suggesting opioid misuse, the patient may be considered ‘drug dependent’
based on the extreme OMEDD of 560mg. Medical practitioners are advised to apply to PSU for an Authority to prescribe
ANY Schedule 8 drug. [See Regulatory requirements]
Key Message:
Neuropathic pain and anxiety are often poorly opioid responsive.
Preventing and managing problems with opioid prescribing for chronic non-cancer pain | July 2015
15
References
[1] Blyth FM, March LM, Brnabic AJ, et al. Chronic pain in
Australia: a prevalence study. Pain 2001; 89: 127-134
[PMID: 11166468]
[2] Cohen ML, Wodak AD. Opioid prescribing in general
practice: a proposed approach. Medicine Today 2012;
13(1): 24-32
[3] Krebs EE, Lorenz KA, Bair MJ, et al. Development and
Initial Validation of the PEG, a Three-item Scale
Assessing Pain Intensity and Interference. J Gen Intern
Med 2009; 24(6): 733-8 [PMID: 19418100]
[4] Analgesic Expert Group. Therapeutic Guidelines: Analgesic.
Version 6. Melbourne: Therapeutic Guidelines Limited,
2012.
[5] Macintyre PE, Schug SA, Scott DA, Visser EJ, Walker SM;
APM:SE Working Group of the Australian and New Zealand
College of Anaesthetists and Faculty of Pain Medicine
(2010), Acute Pain Management: Scientific Evidence (3rd
edition), ANZCA & FPM, Melbourne. http://www.fpm.anzca.
edu.au/resources/books-and-publications/
[6] Caraceni A, Hanks G, Kassa S et al. Use of opioid
analgesics in the treatment of cancer pain: evidence-based
recommendations from the EAPC. Lancet Oncol 2012; 13:
e58-68 [PMID: 22300860]
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NSW TAG | New South Wales Therapeutic Advisory Group Inc
[7] NHS National Institute for Health and Care Excellence
(NICE). Opioids in palliative care: safe and effective
prescribing of strong opioids for pain in palliative care of
adults (CG140), May 2012 [Accessed at http://publications.
nice.org.uk/opioids-in-palliative-care-safe-and-effectiveprescribing-of-strong-opioids-for-pain-in-palliative-cg140 on
27 March 2014]
[8] Amato L, Davoli M, Perucci C et al. An overview of
systematic reviews of the effectiveness of opiate
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clinical practice and research. Journal of Substance Abuse
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[9] Faculty of Pain Medicine, Australian and New Zealand
College of Anaesthetists. Recommendations regarding the
use of opioid analgesics in patients with chronic noncancer pain. June 2015
[10] Cohen ML, Wodal AD. The judicious use of opioids in
managing chronic noncancer pain. Medicine Today
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[11] Australian Medicines Handbook 2014 (online).
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Appendices
Appendix 1: Process of guidance development
This guidance was prepared by a Project Team (MC, AD,
AB), with the support and advice regarding content and
scenario development from a multidisciplinary Subject
Matter Expert Advisory Group (see Appendix 2), which
was convened by the NSW Therapeutic Advisory Group
(TAG) Editorial Committee, as per its published guidance
development processes. Guidance development included
a) review of published research evidence; b) input from a
multidisciplinary group of health professionals from hospital
and primary care settings with recognised expertise in
pain medicine, addiction medicine, paediatric, adult and
geriatric clinical pharmacology and therapeutics, regulatory
management of drugs of addiction, health technology
assessment and medicines evaluation and clinical
pharmacy; and, c) external consultation via invitation with
key national organisations.
Appendix 2: Acknowledgments
The contribution of the following members of the multidisciplinary Subject Matter Expert Advisory Group is gratefully acknowledged.
Expert Advisory Group
Professor Milton Cohen (MC) [Chair], Specialist Pain
Medicine Physician and Rheumatologist, St. Vincent’s
Campus, Sydney
Mr Phillip Bannon, Principal Pharmaceutical Officer,
Pharmaceutical Services Unit, Legal and Regulatory
Services Branch, NSW Ministry of Health
Dr Alexandra (Sasha) Bennett (AB), Executive Officer, NSW
Therapeutic Advisory Group
Ms Anna Drew (AD), Project Officer,
NSW Therapeutic Advisory Group
Dr Chris Hayes, Director Hunter Integrated Pain Service;
Medical Co-Chair, NSW Agency for Clinical Innovation Pain
Management Network
Ms Aine Heaney, Design & Development Manager,
NPS MedicineWise
Prof Sarah Hilmer, Head of Department Clinical
Pharmacology and Senior Staff Specialist Aged Care, Royal
North Shore Hospital and University of Sydney
Dr Simon Holliday, General Practitioner and Staff Specialist,
Drug and Alcohol Clinical Services, Taree
Dr Greg Kelly, Medical Fellow, Pain Medicine and Palliative
Care, Children’s Hospital Westmead
Ms Judith Mackson, Chief Pharmacist and Associate
Director, Pharmaceutical Services Unit, Legal and
Regulatory Services Branch, NSW Ministry of Health
Dr Bridin Murnion, Head of Department, Drug Health
Services, Concord Repatriation General Hospital; Staff
Specialist, Drug Health Services, Royal Prince Alfred
Hospital; Clinical Senior Lecturer, Discipline of Addiction
Medicine, Faculty of Medicine, University of Sydney
Dr Hester Wilson, Staff Specialist in Addiction Medicine,
The Langton Centre, and General Practitioner in private
practice in Metropolitan Sydney
External Consultation
NSW TAG acknowledges with thanks the assistance of
individuals and organisations who provided comments
and constructive suggestions during the external
consultation process.
Agency for Clinical Innovation (ACI) Pain Management
Network
Australian College of Rural and Remote Medicine
Clinical Excellence Commission, NSW
Dr David Gronow, Sydney Pain Management Centre,
Westmead Hospital
NPS MedicineWise
Royal Australasian College of Physicians
Professor Stephan Schug, Chair of Anaesthesiology,
Pharmacology, Pharmacy and Anaesthesiology Unit, School
of Medicine and Pharmacology, University of Western
Australia and Director of Pain Medicine, Royal Perth
Hospital
© NSW Therapeutic Advisory Group Inc and State of New South Wales (through the Ministry of Health) 2015
This work is copyright. Apart from any use as permitted under the Copyright
Act 1968, no part of this information may be reproduced by any process
without written permission of NSW Therapeutic Advisory Group and the NSW
Ministry of Health.
Whilst the information contained in this document has been presented with all
due care, and the information is considered to be true and correct at the date
of publication, changes in circumstances after publication may impact on the
accuracy of the information.
This document represents expert consensus opinion and should not be relied
on as professional advice other than in this context. The information provided
should not be regarded as a substitute for detailed expert advice in individual
cases. NSW Therapeutic Advisory Group Inc will accept no responsibility
for any loss, claim or damage suffered or caused by any person acting or
refraining from action as a result of any material in this document.
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